Biotech Values

[iwfal]

No, I'm not saying that is a solution. I think the FDA either approves outright and cans 02B, or gives an approvable.


Funny - I think the most likely is approved but some kind of direction/dictate (or contingency) on 9902b full enrollment. A variant on Accelerated Approval for which Provenge doesn't officially qualify.

In that sense, it almost sounds to me like this AC was a public way of CBER forwarding an agenda in a controlled, public environment.

Agreed absolutely that was the case. All ACs have that purpose to one degree or another.

FWIW.

Clark